Remission Factors in Anorexia Nervosa (REMANO)

Study of Remission Factors in Anorexia Nervosa of Adult Women (REMANO)

Anorexia Nervosa (AN) is a complex and multifactorial psychiatric disease that affects mostly women and is characterized by a self-restriction of food intake leading to life-threatening consequences whose underlying mechanisms are largely unexplored. AN encompasses a constellation of risk factors including genetic, biological, neuro-psychological and social factors. Although AN has a prevalence of only 1-3% in the general population, it has the highest mortality rate amongst any psychiatric disorder. Recovery of normal feeding behaviour in patients often requires several months with a large between-patient variability and a high percentage of relapse, which can occur in 35 to 41% of the patients. There is a huge unmet need for optimal understanding of processes underlying relapse. Reward processing abnormalities represents an important hypothesis underlying AN development and perpetuation. We aim to investigate the mechanisms that contribute to the maintenance and chronicity of the disease after inpatient treatment with a longitudinal design across intensive standardized inpatient treatment. We will challenge our hypothesis through brain imaging, neuropsychological, metabolic and genetic approaches. One hundred twenty-five AN female patients admitted for intensive inpatient treatment will be recruited and evaluated: at admission, after weight recovery and at 6 months after discharge with neurocognitive tests (including the Delay Discounting Task), genetic/epigenetic examination, hormonal blood samples (at each visit and repeated sampling around a meal for a 10-patient subgroup) and brain imaging (including fMRI during a Delay Discounting Task for fifty patients). One hundred healthy controls will be also recruited and be subjected to the same study procedures.

Study Overview

• Status: Recruiting
• Conditions: Anorexia Nervosa

• Study Type: Observational
• Enrollment (Anticipated): 225

Contacts and Locations

• Study Contact: Name: Philibert Duriez, MD; Phone Number: +33145658345; Email: p.duriez@ghu-paris.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Centre Hospitalier St Anne
    • Principal Investigator: Philip GORWOOD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients :

all female patients integrating inpatient treatment program for Anorexia Nervosa at the Clinique des Maladies Mentales et de l'Encéphale in Paris, France

Control group :

Female aged from 18 to 65 years old without any psychiatric disorder

Description

Inclusion Criteria:

• DMS 5 criteria for Anorexia Nervosa
• BMI < 18.5 kg/m²
• Being able to consent
• fluent in French
• Being affiliated to a social security scheme or being the beneficiary of such a scheme.
• Having signed the informed consent

Exclusion Criteria:

• Deprived of liberty subject (judicial or administrative decision)
• Refusal to participate
• Presenting an unstabilized serious physical illness or psychiatric disorder compromising the follow up according investigator evaluation
• Contraindication for IRMf
• Pregnant or breast-feeding women

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Control Subjects
Anorexia Nervosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay Discounting Task score after weight recovery	Comparaison of this score to remission status six months post discharge	after complete weight recovery (4+/-2 months after inclusion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay Discounting Task score after weight recovery compared to control		after weight recovery (4+/-2 months after baseline)
Bold signal difference during Delay Discounting Task in fMRI		Baseline (M0) and after weight recovery for patient (4+/-2 months after baseline) ; Baseline and 4 months later for healthy controls
Evolution of brain volums in MRI		Baseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of fronto striatal connectivity in MRI		Baseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of total, acyl and desacyl ghrelin plasma level		Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of total, acyl and desacyl ghrelin plasma level around a meal		Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal
Exome analysis		Baseline (M0)
Evolution of BDNF gene methylation		Baseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of EDI-2 score	Evaluate the evolution of eating disorder dimensions during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of EAI score	Evaluate the evolution of physical activity addiction during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of GLT score	Evaluate the evolution of the level of physical activity during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of YBS score	Evaluate the evolution of obession and compulsion during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of HADS score	Evaluate the evolution of anxiety and depression during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of Brixton score	Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of TMT score	Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of Slips of action neurocognitive score	Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of pupillometry to social, food and body image pictures	Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: genetic; anorexia nervosa; delay discounting; ghrelin; epigenetic; eating disorder
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: C18-39; 2019-A01352-55 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No